STAT Palm-Sized Blood Counter

STAT 掌上型血液计数器

基本信息

批准号：
9274352
负责人：
Eugene Yan-ho Chan
金额：
$ 100万
依托单位：
DNA MEDICINE INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-02-09 至 2019-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9274352
关键词：
Accident and Emergency department Ambulances Blood Blood Platelets Blood Tests Blood specimen Boston Caring Cell Size Clinic Collaborations Complete Blood Count Data Developing Countries Development Development Plans Devices Drops Electronic Mail Engineering Ensure Flow Cytometry Foundations Funding Hematology Hemoglobin Hemorrhage Infection Injection of therapeutic agent Intellectual Interest Intellectual Property Laboratories Legal patent Letters Measurement Measures Medical Microfluidics Modeling Molds Optics Pediatric Hospitals Performance Persons Phase Prize Public Health Red Blood Cell Count Reproducibility Research Risk Sampling Specimen Techniques Technology Testing Validation Vendor Venous White Blood Cell Count procedure Whole Blood Work cost design electric impedance miniaturize pediatric patients product development public health relevance rapid diagnosis sensor success technology validation

项目摘要

DESCRIPTION (provided by applicant): The overarching objective of this proposal is to attain data for FDA 510(k) submission of a handheld miniaturized STAT Blood Counter using 5-10 µL blood to yield a complete blood count (CBC) with 3-part differential. This dramatically decreased size and sample volume creates new opportunities in delivery of these hematology tests, ultimately leading to more streamlined, available, and on demand care. In Phase I, we showed proof-of-concept for our microfluidic approach for blood dilution, developed a miniature flow cytometry module, and demonstrated impedance measurements of blood. In Phase II, we developed a microvolume sample consumable, demonstrated blood dilution in our spiral vortexer micromixer, brought our miniature optical block's performance up to par with larger cytometers, and developed a concept model of our blood sensor. Here in this Phase IIB, we plan to fully engineer a product version of our STAT Blood Counter and validate it at Boston Children's Hospital. We are proposing that most of the product development will occur in Years 1-2 and the validation and submission in Year 3. At the conclusion of the effort, we will have submitted our technology for FDA 510(k) approval for CBC with 3-part differential. This will enable capabilities for measuring blood loss, infection, and bleeding risk in a range of different settings including the clinic, emergency rooms, ambulances, developing countries, and the field.

描述（由适用提供）：该提案的总体目标是获得FDA 510（k）使用5-10 µL血液来提交手持式微型统计血液计数器的数据，以产生具有3部分差异的完整血细胞计数（CBC）。这种大小改善的大小和样本量为这些血液学测试提供了新的机会，最终导致更精简，可用和满意的护理。第一阶段，我们显示了我们的微流体方法的概念验证，以进行血液稀释，开发了微型流式细胞仪模块，并证明了对血液的阻抗测量。在第二阶段中，我们开发了一种可消耗的微量液样品，在螺旋涡流微质子中证明了血液稀释，使我们的微型光学块的性能达到了较大的细胞仪，并开发了我们血液传感器的概念模型。在此阶段，我们计划在波士顿儿童医院（Boston Children's Hospital）验证我们的Stat Blood Counter的产品版本。我们提出，大多数产品开发将在1 - 2年内发生，并在第3年进行验证和提交。在努力结束时，我们将向FDA 510（k）批准CBC的技术和3部分差异。这将使在包括诊所，急诊室，救护车，发展中国家和领域在内的各种不同环境中衡量失血，感染和出血风险的能力。